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GRT-C903

Phase 1

Non-Small Cell Lung Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 13, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

GRT-C903 · 1 trial · 5 indications

Phase 1 1
NCT03953235A Study of a Personalized Cancer Vaccine Targeting Shared NeoantigensNon-Small Cell Lung Cancer
COMPLETED39 Analytics
PHASE1COMPLETED
A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs)
Initiation of study treatment through 100 days post-last dose (up to approximately 27 months)
Objective Response Rate (ORR) in Phase 2 using RECIST v1.1
Initiation of study treatment until disease progression (up to approximately 27 months)
Identify the recommended Phase 2 dose (RP2D) of GRT-C903 and GRT-R904
Up to approximately 6 months

Secondary Endpoints

Measure the immune response to the neoantigens encoded by GRT-C903 and GRT-R904
Baseline to end of treatment (up to approximately 12 months)
Objective Response Rate (ORR) in Phase 1 using RECIST v1.1
Initiation of study treatment until disease progression (up to approximately 27 months)
Duration of response (DOR) using RECIST v1.1
Initiation of study treatment until disease progression (up to approximately 27 months)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1EXPERIMENTAL* GRT-C903 * GRT-R904 * nivolumab * ipilimumab
Phase 2EXPERIMENTAL* GRT-C903 * GRT-R904 * nivolumab * ipilimumab Phase 2 for some patients includes a monthly or every two month treatment schedule

Interventions

NameTypeDescription
GRT-C903BIOLOGICALa shared neoantigen cancer vaccine prime
GRT-R904BIOLOGICALa shared neoantigen cancer vaccine boost
nivolumabBIOLOGICALanti-PD-1 monoclonal antibody
ipilimumabBIOLOGICALanti-CTLA-4 monoclonal antibody
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Provide a signed and dated informed consent form prior to initiation of study-specific procedures. * Patients with the indicated advanced or metastatic solid tumor as follows: 1. Microsatellite-stable colorectal cancer (MSS-CRC) who are currently receiving systemic treatmen...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about GRT-C903

What is GRT-C903 used for?

GRT-C903 is an investigational monoclonal antibody being studied for the treatment of Non-Small Cell Lung Cancer. It is a personalized cancer vaccine designed to target shared neoantigens in solid tumors. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes GRT-C903?

GRT-C903 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical research on this investigational monoclonal antibody for oncology applications, specifically in Non-Small Cell Lung Cancer.

What phase is GRT-C903 in?

GRT-C903 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under clinical investigation for Non-Small Cell Lung Cancer.

What clinical trials is GRT-C903 in?

GRT-C903 has one completed Phase 1 clinical trial registered under NCT03953235, titled 'A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens.' The trial enrolled 39 participants and was conducted in the United States, involving patients with Non-Small Cell Lung Cancer and other solid tumors.

Is GRT-C903 the same as a personalized cancer vaccine?

GRT-C903 is a personalized cancer vaccine targeting shared neoantigens. It is designed to treat solid tumors, including Non-Small Cell Lung Cancer. The drug is being studied as a monoclonal antibody-based vaccine approach in an ongoing clinical development program.